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Bay 2927088

A groundbreaking clinical trial is underway to assess the effectiveness and safety of BAY 2927088, a novel oral medication for patients with advanced non-small cell lung cancer (NSCLC) harboring HER2 mutations. This Phase 3 study aims to compare BAY 2927088 with standard of care treatments as a first-line therapy, potentially offering new hope for patients with this specific type of lung cancer.

Table of Contents

What is BAY 2927088?

BAY 2927088 is a new medication being developed by Bayer AG for the treatment of advanced non-small cell lung cancer (NSCLC) with specific genetic mutations[1]. It is currently being studied in clinical trials to evaluate its effectiveness and safety compared to standard treatments.

Target Condition: Advanced Non-Small Cell Lung Cancer with HER2 Mutations

BAY 2927088 is designed to treat a specific type of lung cancer called non-small cell lung cancer (NSCLC). This medication targets NSCLC that has either spread to other parts of the body (metastatic) or is in an advanced stage that cannot be treated with curative intent[1].

Importantly, BAY 2927088 is specifically for patients whose cancer cells have mutations in a gene called HER2 (also known as ERBB2). HER2 mutations are changes in the genetic code that can cause cancer cells to grow and spread more aggressively[1].

How BAY 2927088 Works

While the exact mechanism is not fully described in the provided information, BAY 2927088 is likely designed to target and inhibit the effects of the mutated HER2 gene in cancer cells. By doing so, it may help to slow down or stop the growth and spread of the cancer[1].

Clinical Trial Details

BAY 2927088 is currently being studied in a Phase 3 clinical trial. This is an advanced stage of research that compares the new treatment to existing standard treatments. Key details of the trial include:

  • It is an open-label, randomized, active-controlled, multicenter trial[1].
  • The study aims to evaluate BAY 2927088 as a first-line therapy, meaning it would be used as the initial treatment for eligible patients[1].
  • BAY 2927088 is taken orally in the form of coated tablets[1].
  • The maximum daily dose being studied is 40 mg[1].

Potential Benefits of BAY 2927088

The clinical trial is designed to assess several potential benefits of BAY 2927088, including:

  1. Progression-free survival (PFS): This measures how long patients live without their cancer getting worse[1].
  2. Overall survival (OS): This looks at how long patients live overall[1].
  3. Objective response rate (ORR): This measures the percentage of patients whose tumors shrink or disappear after treatment[1].
  4. Disease control rate (DCR): This includes patients whose disease improves, stays stable, or progresses more slowly[1].
  5. Duration of response (DOR): This measures how long the treatment continues to work in patients who respond[1].

Eligibility Criteria

To participate in the clinical trial for BAY 2927088, patients must meet certain criteria. Some key eligibility requirements include:

  • Age 18 or older[1].
  • Confirmed diagnosis of advanced non-squamous NSCLC[1].
  • Presence of HER2 mutations in the tumor, confirmed by a molecular test[1].
  • No prior systemic therapy for advanced or metastatic disease[1].
  • Eligible to receive standard platinum-based chemotherapy and immunotherapy[1].

There are also several exclusion criteria, such as certain other medical conditions or prior treatments, that might prevent participation[1].

Safety and Side Effects

As with any new medication, monitoring for safety and side effects is a crucial part of the clinical trial. The study will track adverse events, which are any unfavorable changes in health that occur during the trial. These will be categorized by severity to help understand the safety profile of BAY 2927088[1].

Patient-Reported Outcomes

An important aspect of this trial is the focus on patient-reported outcomes. This means that patients will be asked to provide information about how they feel and function while on the treatment. Specific areas that will be assessed include:

  • Lung cancer symptoms such as cough, pain, shortness of breath, fatigue, and appetite[1].
  • Physical functioning and overall quality of life[1].

These patient-reported outcomes help to provide a more complete picture of how the treatment affects patients’ daily lives, beyond just the medical test results.

Aspect Details
Study Type Phase 3, open-label, randomized, active-controlled, multicenter trial
Drug BAY 2927088 (oral medication)
Condition Advanced non-small cell lung cancer (NSCLC) with HER2 mutations
Main Objective Evaluate progression-free survival (PFS) compared to standard of care
Key Secondary Objectives Overall survival, objective response rate, safety, patient-reported outcomes
Key Eligibility Adults with confirmed HER2 mutation, no prior systemic therapy for advanced disease
Key Exclusions Active brain metastases, severe hypersensitivity to monoclonal antibodies, certain lung conditions
Treatment Duration Up to 36 months
Maximum Daily Dose 40 mg
Route of Administration Oral use

FAQ

  • What is BAY 2927088? BAY 2927088 is a new oral medication being studied for the treatment of advanced non-small cell lung cancer (NSCLC) with HER2 mutations. It is designed to target specific genetic changes in lung cancer cells.
  • Who is eligible for this clinical trial? The trial is open to adults (18 years or older) with locally advanced or metastatic non-squamous NSCLC that has a confirmed HER2 mutation. Participants must not have received prior systemic therapy for advanced disease and must be eligible for standard platinum-based chemotherapy with pembrolizumab.
  • What is the main goal of this study? The primary objective is to evaluate how well BAY 2927088 works compared to standard of care treatments in terms of progression-free survival (PFS), which is the length of time patients live without their cancer getting worse.
  • What are some of the key things being measured in this trial? Besides PFS, the study will measure overall survival, how many patients respond to treatment (objective response rate), how long the responses last, safety and side effects, and quality of life outcomes reported by patients.
  • Are there any specific reasons why someone might not be able to participate? Yes, some exclusion criteria include having other targetable genetic alterations (except HER2 mutations), active brain metastases, severe hypersensitivity to monoclonal antibodies, certain lung conditions like interstitial lung disease, and inability to swallow pills or absorb oral medications due to gastrointestinal issues.

Ongoing Clinical Trials on Bay 2927088

  • Study on the Effectiveness and Safety of BAY 2927088 for Patients with Advanced Solid Tumors with HER2 Mutations

    Recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    Denmark France Italy Spain

  • Study on the Effectiveness and Safety of BAY 2927088 Compared to Standard Treatment in Patients with Advanced Non-Small Cell Lung Cancer with HER2 Mutations

    Recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Belgium Bulgaria Czechia Denmark Finland +12

Glossary

  • Non-small cell lung cancer (NSCLC): The most common type of lung cancer, accounting for about 80-85% of all cases. It grows and spreads more slowly than small cell lung cancer.
  • HER2 mutation: A change in the HER2 gene that can cause cells to grow and divide uncontrollably, leading to cancer. In this study, it refers specifically to mutations in the tyrosine kinase domain of the HER2 gene.
  • Progression-free survival (PFS): The length of time during and after treatment that a patient lives with cancer without it getting worse.
  • Overall survival (OS): The length of time from the start of treatment or diagnosis that patients are still alive.
  • Objective response rate (ORR): The percentage of patients whose cancer shrinks or disappears after treatment.
  • RECIST 1.1: Response Evaluation Criteria in Solid Tumors version 1.1, a standard way to measure how well a cancer patient responds to treatment.
  • Blinded Independent Central Review (BICR): A process where medical experts who don't know the patient's treatment review test results to determine how well the treatment is working.
  • Standard of Care (SoC): The currently accepted and widely used treatment for a specific condition.
  • Patient-reported outcomes (PROs): Information about how patients feel and function that comes directly from the patients themselves.
  • CTCAE: Common Terminology Criteria for Adverse Events, a system for describing the severity of side effects in cancer therapy.

References

  1. http://clinicaltrials.eu/trial/study-on-the-effectiveness-and-safety-of-bay-2927088-compared-to-standard-treatment-in-patients-with-advanced-non-small-cell-lung-cancer-with-her2-mutations/